Agency Information Collection Activities; Proposed Collection; Public Comment Request; Centers for Independent Living Program Performance Report (0985-0061), 94732-94734 [2024-28052]
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94732
Federal Register / Vol. 89, No. 230 / Friday, November 29, 2024 / Notices
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FOR FURTHER INFORMATION CONTACT:
William Parham at (410) 786–4669.
SUPPLEMENTARY INFORMATION: Under the
Paperwork Reduction Act of 1995 (PRA)
(44 U.S.C. 3501–3520), federal agencies
must obtain approval from the Office of
Management and Budget (OMB) for each
collection of information they conduct
or sponsor. The term ‘‘collection of
information’’ is defined in 44 U.S.C.
3502(3) and 5 CFR 1320.3(c) and
includes agency requests or
requirements that members of the public
submit reports, keep records, or provide
information to a third party. Section
3506(c)(2)(A) of the PRA (44 U.S.C.
3506(c)(2)(A)) requires federal agencies
to publish a 30-day notice in the
Federal Register concerning each
proposed collection of information,
including each proposed extension or
reinstatement of an existing collection
of information, before submitting the
collection to OMB for approval. To
comply with this requirement, CMS is
publishing this notice that summarizes
the following proposed collection(s) of
information for public comment:
1. Type of Information Collection
Request: Reinstatement without change
of a previously approved collection;
Title: Medicare Program: Procedures for
Making National Coverage Decisions;
Use: This collection is required by a
notice (78 FR 48164–69) published on
August 7, 2013 which delineates the
process for making a national coverage
determination (NCD) including
information for external parties to
submit a formal request for a new NCD
or a reconsideration of an existing NCD.
An NCD is defined in 1862(l) of the
Social Security Act (the Act) as ‘‘a
determination by the Secretary with
respect to whether or not a particular
item or service is covered nationally
under this title.’’ This information
collection will assist us in obtaining the
information we require to make a
national coverage determination in a
timely manner and ensuring that the
Medicare program continues to meet the
needs of its beneficiaries. Form Number:
CMS–R–290 (OMB control number:
0938–0776); Frequency: Annual;
Affected Public: Private Sector: Business
or other for-profits; Number of
Respondents: 30; Total Annual
Responses: 30; Total Annual Hours:
1,200. (For policy questions regarding
this collection contact Lori M. Ashby at
410–786–6322.)
2. Type of Information Collection
Request: Reinstatement without change
of a previously approved collection:
Title of Information Collection:
Transcatheter Valve Therapy (TVT)
Registry; Use: The data collection is
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required by the Centers for Medicare
and Medicaid Services (CMS) National
Coverage Determination (NCD) entitled,
‘‘Transcatheter Aortic Valve
Replacement (TAVR)’’. The TAVR
device is only covered when specific
conditions are met including that the
heart team and hospital are submitting
data in a prospective, national, audited
registry. The data includes patient,
practitioner and facility level variables
that predict outcomes such as all cause
mortality and quality of life. CMS finds
that the Society of Thoracic Surgery/
American College of Cardiology
Transcatheter Valve Therapy (STS/ACC
TVT) Registry, one registry overseen by
the National Cardiovascular Data
Registry, meets the requirements
specified in the NCD on TAVR. The
TVT Registry will support a national
surveillance system to monitor the
safety and efficacy of the TAVR
technologies for the treatment of aortic
stenosis.
The data will also include the
variables on the eight item Kansas City
Cardiomyopathy Questionnaire (KCCQ–
10) to assess heath status, functioning
and quality of life. In the KCCQ, an
overall summary score can be derived
from the physical function, symptoms
(frequency and severity), social function
and quality of life domains. For each
domain, the validity, reproducibility,
responsiveness and interpretability have
been independently established. Scores
are transformed to a range of 0–100, in
which higher scores reflect better health
status.
The conduct of the STS/ACC TVT
Registry and the KCCQ–10 is in
accordance with Section 1142 of the
Social Security Act (the Act) that
describes the authority of the Agency for
Healthcare Research and Quality
(AHRQ). Under section 1142, research
may be conducted and supported on the
outcomes, effectiveness, and
appropriateness of health care services
and procedures to identify the manner
in which disease, disorders, and other
health conditions can be prevented,
diagnosed, treated, and managed
clinically. Section 1862(a)(1)(E) of the
Act allows Medicare to cover under
coverage with evidence development
(CED) certain items or services for
which the evidence is not adequate to
support coverage under section
1862(a)(1)(A) and where additional data
gathered in the context of a clinical
setting would further clarify the impact
of these items and services on the health
of beneficiaries.
The data collected and analyzed in
the TVT Registry will be used by CMS
to determine if the TAVR is reasonable
and necessary (e.g., improves health
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outcomes) for Medicare beneficiaries
under Section 1862(a)(1)(A) of the Act.
Furthermore, data from the Registry will
assist the medical device industry and
the Food and Drug Administration
(FDA) in surveillance of the quality,
safety and efficacy of new medical
devices to treat aortic stenosis. For
purposes of the TAVR NCD, the TVT
Registry has contracted with the Data
Analytic Centers to conduct the
analyses. In addition, data will be made
available for research purposes under
the terms of a data use agreement that
only provides de-identified datasets.
Form Number: CMS–10443 (OMB
control number: 0938–1202); Frequency:
Annual; Affected Public: Individuals,
Households and Private Sector; Number
of Respondents: 49,704; Total Annual
Responses: 198,816; Total Annual
Hours: 63,790. (For policy questions
regarding this collection contact Nina
Arya at 667–290–9456).
William N. Parham, III,
Director, Division of Information Collections
and Regulatory Impacts, Office of Strategic
Operations and Regulatory Affairs.
[FR Doc. 2024–28077 Filed 11–27–24; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Community Living
Agency Information Collection
Activities; Proposed Collection; Public
Comment Request; Centers for
Independent Living Program
Performance Report (0985–0061)
Administration for Community
Living, HHS.
AGENCY:
ACTION:
Notice.
The Administration for
Community Living (ACL) is announcing
an opportunity for the public to
comment on the proposed collection of
information listed above. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal agencies are required to
publish a notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension of an existing collection of
information, and to allow 60 days for
public comment in response to the
notice. This proposed revision of a
currently approved information
collection request (ICR Rev) solicits
comments on the information collection
requirements related to the Centers for
Independent Living (CILs) under the
Rehabilitation Act of 1973, 29 U.S.C.
701, et seq. (the Act).
SUMMARY:
E:\FR\FM\29NON1.SGM
29NON1
Federal Register / Vol. 89, No. 230 / Friday, November 29, 2024 / Notices
Comments on the collection of
information must be submitted
electronically by 11:59 p.m. (ET) or
postmarked by January 28, 2025.
DATES:
Submit electronic
comments on the collection of
information to: Peter Nye at
OILPPRAComments@acl.hhs.gov.
Submit written comments on the
collection of information to
Administration for Community Living,
Washington, DC 20201, Attention: Peter
Nye.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Peter Nye, Administration for
Community Living, Washington, DC
20024, (202) 795–7606 or
OILPPRAComments@acl.hhs.gov.
Under the
PRA (44 U.S.C. 3501–3520), Federal
agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information,
before submitting the collection to
Office of Management and Budget for
approval. To comply with this
requirement, ACL is publishing a notice
of the proposed collection of
information set forth in this document.
With respect to the following collection
of information, ACL invites comments
on our burden estimates or any other
aspect of this collection of information,
including:
(1) whether the proposed collection of
information is necessary for the proper
performance of ACL’s functions,
khammond on DSK9W7S144PROD with NOTICES
SUPPLEMENTARY INFORMATION:
including whether the information will
have practical utility;
(2) the accuracy of ACL’s estimate of
the burden of the proposed collection of
information, including the validity of
the methodology and assumptions used
to determine burden estimates;
(3) ways to enhance the quality,
utility, and clarity of the information to
be collected; and
(4) ways to minimize the burden of
the collection of information on
respondents, including through the use
of automated collection techniques
when appropriate, and other forms of
information technology.
Independent living (IL) programs,
including CILs, are authorized by the
Act to ‘‘promote a philosophy of
independent living including a
philosophy of consumer control, peer
support, self-help, self-determination,
equal access, and individual and system
advocacy, in order to maximize the
leadership, empowerment,
independence, and productivity of
individuals with disabilities, and the
integration and full inclusion of
individuals with disabilities into the
mainstream of American society’’ (Title
VII, chapter 1). This request is for the
CIL Program Performance Report (PPR),
which is submitted annually by all CILs
receiving IL Subchapter C funds. The
PPRs are used by ACL to assess
grantees’ compliance with title VII of
the Act, with 45 CFR part 1329 of the
Code of Federal Regulations, and with
applicable provisions of the HHS
Regulations at 45 CFR part 75. The PPR
serves as the primary basis for ACL’s
monitoring activities in fulfillment of its
responsibilities under sections 706 and
722 of the Act. The PPR is also used by
ACL to design CIL and Statewide
Independent Living Council training
and technical assistance programs
authorized by sections 711A and 721 of
the Act.
This revision adds the collection of
sexual-orientation and gender-identity
(SOGI) data elements consistent with
94733
Executive Orders: 13985 Advancing
Racial Equity and Support for
Underserved Communities Through the
Federal Government; 13988 Preventing
and Combating Discrimination on the
Basis of Gender Identity and Sexual
Orientation and 14075 Advancing
Equality for Lesbian, Gay, Bisexual,
Transgender, Queer, and Intersex
Individuals. ACL will adhere to best
practices for collection of all
demographic information in accordance
with Office of Management and Budget
(OMB) guidance—including, but not
limited to guidance specific to the
collection of SOGI. In addition,
measures were added around the nature
of CIL board governance and number of
full-time equivalent positions filled by
individuals with significant disabilities
to affirm adherence to statutory
requirements. Additional measures were
also added to allow CILs to report
carryover funding and to count the total
number of services provided by
consumer, as well as to describe their
collaborations. These measures were
added based on the request of
stakeholders to yield more precise data
that show impact. With the addition of
these four measures, eleven other
measures are suggested to be removed to
increase efficiency and remove
redundancy and unnecessary
information. The revised CIL PPR
instrument is expected to take less time
than the prior instrument.
The proposed data collection tool may
be found on the ACL website for review
at https://www.acl.gov/about-acl/publicinput.
Estimated Program Burden
ACL estimates the burden for new
measures added as follows: 351 CILs
completing one CIL PPR annually,
taking an estimated time of 36 hours per
CIL for total of 12,708 annual burden
hours. This burden estimate is based
partly on OILP’s estimates of how long
CILs take to complete the PPRs as well
as feedback gathered from CILs to ACL.
Respondent/data collection activity
Number of
respondents
Responses
per
respondent
Hours per
response
Annual burden
hours
CIL ...................................................................................................................
351
1
36
12,636
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94734
Federal Register / Vol. 89, No. 230 / Friday, November 29, 2024 / Notices
Dated: November 25, 2024.
Maura Calsyn,
Principal Deputy Administrator for the
Administration for Community Living,
performing the delegable duties of the
Administrator and the Assistant Secretary for
Aging.
[FR Doc. 2024–28052 Filed 11–27–24; 8:45 am]
BILLING CODE 4154–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2024–N–4731]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Administrative
Detention and Banned Medical Devices
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
announcing an opportunity for public
comment on the proposed collection of
certain information by the Agency.
Under the Paperwork Reduction Act of
1995 (PRA), Federal Agencies are
required to publish notice in the
Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information, and
to allow 60 days for public comment in
response to the notice. This notice
solicits comments on information
collection associated with
administrative detention and banned
medical devices.
DATES: Either electronic or written
comments on the collection of
information must be submitted by
January 28, 2025
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. The https://
www.regulations.gov electronic filing
system will accept comments until
11:59 p.m. Eastern Time at the end of
January 28, 2025. Comments received by
mail/hand delivery/courier (for written/
paper submissions) will be considered
timely if they are received on or before
that date.
khammond on DSK9W7S144PROD with NOTICES
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
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21:22 Nov 27, 2024
Jkt 265001
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2024–N–4731 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request;
Administrative Detention and Banned
Medical Devices.’’ Received comments,
those filed in a timely manner (see
ADDRESSES), will be placed in the docket
and, except for those submitted as
‘‘Confidential Submissions,’’ publicly
viewable at https://www.regulations.gov
or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday
through Friday, 240–402–7500.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
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claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://
www.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852, 240–402–7500.
FOR FURTHER INFORMATION CONTACT:
Amber Sanford, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–8867, PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3521), Federal
Agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
Agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) whether
the proposed collection of information
is necessary for the proper performance
E:\FR\FM\29NON1.SGM
29NON1
]]>Agencies
[Federal Register Volume 89, Number 230 (Friday, November 29, 2024)]
[Notices]
[Pages 94732-94734]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-28052]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Community Living
Agency Information Collection Activities; Proposed Collection;
Public Comment Request; Centers for Independent Living Program
Performance Report (0985-0061)
AGENCY: Administration for Community Living, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Administration for Community Living (ACL) is announcing an
opportunity for the public to comment on the proposed collection of
information listed above. Under the Paperwork Reduction Act of 1995
(the PRA), Federal agencies are required to publish a notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This proposed revision of a currently approved information
collection request (ICR Rev) solicits comments on the information
collection requirements related to the Centers for Independent Living
(CILs) under the Rehabilitation Act of 1973, 29 U.S.C. 701, et seq.
(the Act).
[[Page 94733]]
DATES: Comments on the collection of information must be submitted
electronically by 11:59 p.m. (ET) or postmarked by January 28, 2025.
ADDRESSES: Submit electronic comments on the collection of information
to: Peter Nye at [email protected]. Submit written comments
on the collection of information to Administration for Community
Living, Washington, DC 20201, Attention: Peter Nye.
FOR FURTHER INFORMATION CONTACT: Peter Nye, Administration for
Community Living, Washington, DC 20024, (202) 795-7606 or
[email protected].
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to Office of Management and Budget for
approval. To comply with this requirement, ACL is publishing a notice
of the proposed collection of information set forth in this document.
With respect to the following collection of information, ACL invites
comments on our burden estimates or any other aspect of this collection
of information, including:
(1) whether the proposed collection of information is necessary for
the proper performance of ACL's functions, including whether the
information will have practical utility;
(2) the accuracy of ACL's estimate of the burden of the proposed
collection of information, including the validity of the methodology
and assumptions used to determine burden estimates;
(3) ways to enhance the quality, utility, and clarity of the
information to be collected; and
(4) ways to minimize the burden of the collection of information on
respondents, including through the use of automated collection
techniques when appropriate, and other forms of information technology.
Independent living (IL) programs, including CILs, are authorized by
the Act to ``promote a philosophy of independent living including a
philosophy of consumer control, peer support, self-help, self-
determination, equal access, and individual and system advocacy, in
order to maximize the leadership, empowerment, independence, and
productivity of individuals with disabilities, and the integration and
full inclusion of individuals with disabilities into the mainstream of
American society'' (Title VII, chapter 1). This request is for the CIL
Program Performance Report (PPR), which is submitted annually by all
CILs receiving IL Subchapter C funds. The PPRs are used by ACL to
assess grantees' compliance with title VII of the Act, with 45 CFR part
1329 of the Code of Federal Regulations, and with applicable provisions
of the HHS Regulations at 45 CFR part 75. The PPR serves as the primary
basis for ACL's monitoring activities in fulfillment of its
responsibilities under sections 706 and 722 of the Act. The PPR is also
used by ACL to design CIL and Statewide Independent Living Council
training and technical assistance programs authorized by sections 711A
and 721 of the Act.
This revision adds the collection of sexual-orientation and gender-
identity (SOGI) data elements consistent with Executive Orders: 13985
Advancing Racial Equity and Support for Underserved Communities Through
the Federal Government; 13988 Preventing and Combating Discrimination
on the Basis of Gender Identity and Sexual Orientation and 14075
Advancing Equality for Lesbian, Gay, Bisexual, Transgender, Queer, and
Intersex Individuals. ACL will adhere to best practices for collection
of all demographic information in accordance with Office of Management
and Budget (OMB) guidance--including, but not limited to guidance
specific to the collection of SOGI. In addition, measures were added
around the nature of CIL board governance and number of full-time
equivalent positions filled by individuals with significant
disabilities to affirm adherence to statutory requirements. Additional
measures were also added to allow CILs to report carryover funding and
to count the total number of services provided by consumer, as well as
to describe their collaborations. These measures were added based on
the request of stakeholders to yield more precise data that show
impact. With the addition of these four measures, eleven other measures
are suggested to be removed to increase efficiency and remove
redundancy and unnecessary information. The revised CIL PPR instrument
is expected to take less time than the prior instrument.
The proposed data collection tool may be found on the ACL website
for review at https://www.acl.gov/about-acl/public-input.
Estimated Program Burden
ACL estimates the burden for new measures added as follows: 351
CILs completing one CIL PPR annually, taking an estimated time of 36
hours per CIL for total of 12,708 annual burden hours. This burden
estimate is based partly on OILP's estimates of how long CILs take to
complete the PPRs as well as feedback gathered from CILs to ACL.
----------------------------------------------------------------------------------------------------------------
Number of Responses per Hours per Annual burden
Respondent/data collection activity respondents respondent response hours
----------------------------------------------------------------------------------------------------------------
CIL......................................... 351 1 36 12,636
----------------------------------------------------------------------------------------------------------------
[[Page 94734]]
Dated: November 25, 2024.
Maura Calsyn,
Principal Deputy Administrator for the Administration for Community
Living, performing the delegable duties of the Administrator and the
Assistant Secretary for Aging.
[FR Doc. 2024-28052 Filed 11-27-24; 8:45 am]
BILLING CODE 4154-01-P
